Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure (ASTRONAUT)
15. Oktober 2013 aktualisiert von: Novartis Pharmaceuticals
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the 6 Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality When Initiated Early After Hospitalization for Acute Decompensated Heart Failure
This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
1639
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Buenos Aires, Argentinien
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Buenos Aires, Argentinien, C1050AAK
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Buenos Aires, Argentinien, W3400ABH
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Buenos Aires, Argentinien, C1094AAD
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Buenos Aires, Argentinien, B1650CSQ
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Buenos Aires, Argentinien, B1708KCH
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Buenos Aires, Argentinien, C1201AAO
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Buenos Aires, Argentinien, C1428AQK
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Buenos aires, Argentinien, C1210AAP
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Cordoba, Argentinien, X5006IKK
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Cordoba, Argentinien, X5000AAI
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Corrientes, Argentinien, 3400
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Corrientes, Argentinien, W3400
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Corrientes, Argentinien, W3400CBI
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Quilmes, Argentinien, 1878
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Santa Fe, Argentinien, 3000
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Santa Fe, Argentinien, S2004CMW
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Tucuman, Argentinien, T4000NIJ
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Buenos Aires
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San Nicolas, Buenos Aires, Argentinien, B2900IIC
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Misiones
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Posadas, Misiones, Argentinien, N3300AHX
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Santa Fe
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Rosario, Santa Fe, Argentinien, S2000DSV
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Rosario, Santa Fe, Argentinien, S2001ODA
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Tucuman
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San Miguel de Tucuman, Tucuman, Argentinien, T4000JCU
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Antwerpen, Belgien, 2020
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Brasschaat, Belgien, 2930
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Genk, Belgien, 3600
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Gent, Belgien, 9000
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Hasselt, Belgien, 3500
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Huy, Belgien, 4500
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Leuven, Belgien, 3000
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Mechelen, Belgien, 2800
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Mol, Belgien, 2400
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Namur, Belgien, 5000
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MG
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Belo Horizonte, MG, Brasilien, 30150-221
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Belo Horizonte, MG, Brasilien, 20180-090
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Belo Horizonte, MG, Brasilien
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PR
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Londrina, PR, Brasilien, 86051-990
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RJ
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Rio de Janeiro, RJ, Brasilien, 22261-010
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RS
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Porto Alegre, RS, Brasilien, 90610-000
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SP
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Campinas, SP, Brasilien, 13060-904
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Sao Jose do Rio Preto, SP, Brasilien, 15150-210
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São Paulo, SP, Brasilien, 05403-000
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Augsburg, Deutschland, 86156
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Bad Bevensen, Deutschland, 29549
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Bad Nauheim, Deutschland, 61231
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Berlin, Deutschland, 10249
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Berlin, Deutschland, 10098
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Berlin, Deutschland, 13353
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Berlin, Deutschland, 13347
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Berlin, Deutschland, 13578
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Berlin, Deutschland, 12621
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Kerala
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Kochi, Kerala, Indien, 682 026
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M.p.
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Indore, M.p., Indien, 452001
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Mumbai, Maharashtra, Indien, 400 022
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(pv)
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Pavia, (pv), Italien, 27100
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Verona, (vr), Italien, 37126
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Foggia, FG, Italien, 71100
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Grosseto, GR, Italien, 58100
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Pozzilli, IS, Italien, 86077
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Casarano, LE, Italien, 73042
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Monza, MB, Italien, 20900
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MI
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Legnano, MI, Italien, 20025
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Milano, MI, Italien, 20157
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PA
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Palermo, PA, Italien, 90146
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Perugia, PG, Italien, 06129
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Parma, PR, Italien, 43100
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RM
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Albano Laziale, RM, Italien, 00041
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Roma, RM, Italien, 00189
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Rimini, RN, Italien, 47900
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Siena, SI, Italien, 53100
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Legnago, VR, Italien, 37045
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St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
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Halifax, Nova Scotia, Kanada, B3H 2Y9
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Quebec
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Montreal, Quebec, Kanada, H3T 1E2
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Barranquilla, Kolumbien
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Manila, Philippinen, 1000
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Quezon City, Philippinen, 1100
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Quezon City, Metro Manila, Philippinen, 1109
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District 1
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Bucuresti, District 1, Rumänien, 014461
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Lubertsi, Russische Föderation, 140006
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Moscow, Russische Föderation, 127644
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- Novartis Investigative Site
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Sylmar, California, Vereinigte Staaten, 91342
- Novartis Investigative Site
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Torrance, California, Vereinigte Staaten, 90502
- Novartis Investigative Site
-
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Connecticut
-
Hartford, Connecticut, Vereinigte Staaten, 06102-5037
- Novartis Investigative Site
-
-
District of Columbia
-
Washington, District of Columbia, Vereinigte Staaten, 20037
- Novartis Investigative Site
-
Washington, District of Columbia, Vereinigte Staaten, 20010-2975
- Novartis Investigative Site
-
-
Florida
-
Jacksonville, Florida, Vereinigte Staaten, 32207
- Novartis Investigative Site
-
-
Georgia
-
Macon, Georgia, Vereinigte Staaten, 31201
- Novartis Investigative Site
-
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Illinois
-
Oakbrook Terrace, Illinois, Vereinigte Staaten, 60181
- Novartis Investigative Site
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Iowa
-
Iowa City, Iowa, Vereinigte Staaten, 52245
- Novartis Investigative Site
-
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Louisiana
-
Lafayette, Louisiana, Vereinigte Staaten, 70501
- Novartis Investigative Site
-
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Michigan
-
Detroit, Michigan, Vereinigte Staaten, 48202
- Novartis Investigative Site
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Kalamazoo, Michigan, Vereinigte Staaten, 49048
- Novartis Investigative Site
-
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Missouri
-
St. Louis, Missouri, Vereinigte Staaten, 63110
- Novartis Investigative Site
-
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New Jersey
-
Cherry Hill, New Jersey, Vereinigte Staaten, 08034
- Novartis Investigative Site
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Newark, New Jersey, Vereinigte Staaten, 07103-2714
- Novartis Investigative Site
-
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New York
-
Bronx, New York, Vereinigte Staaten, 10461
- Novartis Investigative Site
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Buffalo, New York, Vereinigte Staaten, 14215
- Novartis Investigative Site
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Buffalo, New York, Vereinigte Staaten, 14203
- Novartis Investigative Site
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Saratoga Springs, New York, Vereinigte Staaten, 12866
- Novartis Investigative Site
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North Carolina
-
Chapel Hill, North Carolina, Vereinigte Staaten, 27599-7075
- Novartis Investigative Site
-
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Ohio
-
Cincinnati, Ohio, Vereinigte Staaten, 45219
- Novartis Investigative Site
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Cincinnati, Ohio, Vereinigte Staaten, 45267-0585
- Novartis Investigative Site
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Cleveland, Ohio, Vereinigte Staaten, 44109-1998
- Novartis Investigative Site
-
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Pennsylvania
-
Philadelphia, Pennsylvania, Vereinigte Staaten, 19140
- Novartis Investigative Site
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19102-1192
- Novartis Investigative Site
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15212
- Novartis Investigative Site
-
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South Carolina
-
Charleston, South Carolina, Vereinigte Staaten, 29403
- Novartis Investigative Site
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South Dakota
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Rapid City, South Dakota, Vereinigte Staaten, 57701
- Novartis Investigative Site
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Tennessee
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Springfield, Tennessee, Vereinigte Staaten, 37172
- Novartis Investigative Site
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Texas
-
Brownsville, Texas, Vereinigte Staaten, 78520
- Novartis Investigative Site
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Virginia
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Charlottesville, Virginia, Vereinigte Staaten, 22908
- Novartis Investigative Site
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Richmond, Virginia, Vereinigte Staaten, 23298
- Novartis Investigative Site
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Richmond, Virginia, Vereinigte Staaten, 23249
- Novartis Investigative Site
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion criteria:
- Patient hospitalized with a primary diagnosis of worsening heart failure ≥ 18 years of age, male or female.
Patients with a diagnosis of acute heart failure expressed by symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization.
- LVEF < 40% (measured within the last 6 months).
- Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP ≥ 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization.
- Elevated BNP at Visit 1 or at randomization (BNP ≥ 400 pg/ml).
- Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).
Exclusion Criteria:
- Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization.
- Concomitant use of ACEI and ARB at randomization.
- Right heart failure due to pulmonary disease.
- Diagnosis of postpartum cardiomyopathy.
- Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
- Patients with a history of heart transplant or who are on a transplant list.
- Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.
Other protocol-defined inclusion/exclusion criteria applied.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Aliskiren
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks.
From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
|
Aliskiren 150 mg and Aliskiren 300 mg
Andere Namen:
|
|
Placebo-Komparator: Placebo
Randomized patients in this arm received matching placebo of Aliskiren.
At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
Placebo
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months
Zeitfenster: 6 months
|
Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable.
For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization).
The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.
|
6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months
Zeitfenster: 12 months
|
Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable.
For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization).
The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months.
|
12 months
|
|
Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months
Zeitfenster: Baseline, 1 months, 6 months and 12 months
|
Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ).
The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction.
Each scale score was calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning.
A score of 100 represents perfect health whereas a score of 0 represents death.
A positive change in score from baseline indicates an improvement.
|
Baseline, 1 months, 6 months and 12 months
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Zeitfenster: 6 months
|
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
|
6 months
|
|
Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months
Zeitfenster: 12 months
|
12 months
|
|
|
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months
Zeitfenster: Baseline, 1 month, 6 months and 12 months
|
The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms.
|
Baseline, 1 month, 6 months and 12 months
|
|
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
Zeitfenster: 12 months
|
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
|
12 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Vaduganathan M, Cheema B, Cleveland E, Sankar K, Subacius H, Fonarow GC, Solomon SD, Lewis EF, Greene SJ, Maggioni AP, Bohm M, Zannad F, Butler J, Gheorghiade M. Plasma renin activity, response to aliskiren, and clinical outcomes in patients hospitalized for heart failure: the ASTRONAUT trial. Eur J Heart Fail. 2018 Apr;20(4):677-686. doi: 10.1002/ejhf.973. Epub 2017 Nov 16.
- Greene SJ, Butler J, Fonarow GC, Subacius HP, Ambrosy AP, Vaduganathan M, Triggiani M, Solomon SD, Lewis EF, Maggioni AP, Bohm M, Chioncel O, Nodari S, Senni M, Zannad F, Gheorghiade M; ASTRONAUT Investigators and Coordinators. Pre-discharge and early post-discharge troponin elevation among patients hospitalized for heart failure with reduced ejection fraction: findings from the ASTRONAUT trial. Eur J Heart Fail. 2018 Feb;20(2):281-291. doi: 10.1002/ejhf.1019. Epub 2017 Oct 17.
- Lund LH, Trochu JN, Meyns B, Caliskan K, Shaw S, Schmitto JD, Schibilsky D, Damme L, Heatley J, Gustafsson F. Screening for heart transplantation and left ventricular assist system: results from the ScrEEning for advanced Heart Failure treatment (SEE-HF) study. Eur J Heart Fail. 2018 Jan;20(1):152-160. doi: 10.1002/ejhf.975. Epub 2017 Sep 27.
- Gheorghiade M, Bohm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, Solomon SD, Baschiera F, Botha J, Hua TA, Gimpelewicz CR, Jaumont X, Lesogor A, Maggioni AP; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA. 2013 Mar 20;309(11):1125-35. doi: 10.1001/jama.2013.1954. Erratum In: JAMA. 2013 Apr 10;309(14):1461.
- Gheorghiade M, Albaghdadi M, Zannad F, Fonarow GC, Bohm M, Gimpelewicz C, Botha J, Moores S, Lewis EF, Rattunde H, Maggioni A; ASTRONAUT investigators and study coordinators. Rationale and design of the multicentre, randomized, double-blind, placebo-controlled Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT). Eur J Heart Fail. 2011 Jan;13(1):100-6. doi: 10.1093/eurjhf/hfq209. Epub 2010 Nov 30.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Mai 2009
Primärer Abschluss (Tatsächlich)
1. August 2012
Studienabschluss (Tatsächlich)
1. August 2012
Studienanmeldedaten
Zuerst eingereicht
5. Mai 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. Mai 2009
Zuerst gepostet (Schätzen)
7. Mai 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
7. November 2013
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
15. Oktober 2013
Zuletzt verifiziert
1. Oktober 2013
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CSPP100A2368
- 2009-010236-18 (EudraCT-Nummer)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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